Arizona Tribune - Onco-Innovations Advances Optimization and Scale-Up of Its PNKP Inhibitor Technology with Dalton Pharma Services to Support Future Phase 1 Clinical Studies

Building on the manufacturing activities previously initiated by Dalton for preclinical testing material (see Company press release dated May 26, 2025), the Company has now advanced to the optimization and intermediate-scale production (for research purposes) of A83B4C63. This next phase focuses on process scale-up and analytical method qualification, which is intended to ensure a robust, reproducible, and scalable manufacturing process suitable for future GMP production and subsequent manufacturing of clinical material to support Onco's IND enabling and Phase 1 studies. The work will be performed using dedicated pilot-scale equipment at Dalton's FDA- and Health Canada-approved facility in Toronto, Canada.

As part of this optimization phase, Dalton will conduct intermediary scale-up batches targeting approximately 500 g of precursor A83 and 1,000 g of precursor B4 to evaluate reaction performance under scale-up conditions in preparation for pre-clinical production of A83B4C63.

The A83B4C63 active pharmaceutical ingredient (API) will be used to support the development of Onco's encapsulated nanoparticle micelle formulation, which is designed with the goal of enhancing tumor-targeted delivery of the PNKP inhibitor, and with the ultimate goal of potentially improving therapeutic efficacy in cancer treatment.

The manufacturing program also includes comprehensive analytical method development and stability testing conducted in accordance with International Council for Harmonisation (ICH) guidelines, as well as a formal safety and risk assessment of A83B4C63 prior to full-scale synthesis. The optimization work encompasses precursor synthesis refinement, process scale-up, and analytical method development in accordance with international quality standards to ensure a robust and reproducible manufacturing process suitable for future GMP production.

"This milestone marks a pivotal transition from lab-scale synthesis to scalable pre-clinical manufacturing of our lead PNKP inhibitor," said Thomas O'Shaughnessy, Chief Executive Officer of Onco-Innovations. "Dalton's deep expertise and regulatory credentials make them an ideal partner as we continue to move towards clinical development. This phase is intended to lay the groundwork for meeting the rigorous standards required for future GMP production and clinical trial readiness."

About Onco-Innovations Limited

Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco's mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.

About Dalton Pharma Services

Dalton Pharma Services, established in 1986 and based in Toronto, Canada, is a Health Canada-approved and FDA-inspected GMP contract provider of integrated chemistry, drug development, and manufacturing services to the pharmaceutical and biotechnology industries. With over 35 years of experience, Dalton offers a comprehensive range of in-house services, including drug discovery, flow chemistry, formulation and process development, custom synthesis, cGMP sterile fill/finish, cGMP API manufacturing, and dosage form manufacturing. This integration at a single location enhances adaptability, flexibility, and cost-effectiveness, accelerating drug discovery and development programs. Dalton's commitment to quality, speed, and flexibility has been recognized with CMO Leadership Awards from Life Science Leader in 2016, 2017, and 2018 across categories such as Quality, Reliability, Capabilities, Expertise, Compatibility, and Development.¹

ON BEHALF OF ONCO-INNOVATIONS LIMITED,

"Thomas O'Shaughnessy"
Chief Executive Officer

For more information, please contact:

Thomas O'Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
[email protected]

Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the Company's expectation that it will be able to continue to pursue and progress its research and development plans, and the Company's ability to move forward with its plans for regulatory approvals and the conduct of clinical and other further testing of its Technologies, the prospects of the Company, and the Company's business and plans generally, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

¹https://www.dalton.com/pharmaceutical-manufacturing

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

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